Imagine Eyes’ quality management receives Korean GMP certificate

We are glad to announce that Imagine Eyes’ quality management system successfully passed the Korea Good Manufacturing Practice (KGMP) inspection for medical device manufacturers.

“The KGMP certificate was required in order to submit our product, the rtx1 AO retinal camera, to market authorization in South Korea. This first milestone being achieved, we keep working with our partner Aracare towards full regulatory clearance. We are looking forward to making cellular-level retinal imaging available to Korean clinicians and patients” said Barbara Lamory-Bardet, Manager of Quality and Regulatory Affairs (QRA) at Imagine Eyes.

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Click here to learn more about Aracare Inc.